Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.

Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies. - Immune-profiling of fresh peripheral blood and/or pleural effusion from non-small cell lung cancer patients treated with anti-PD-1 antibodies.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024623

Enrollment

100

Registered

2016-10-31

Start date

2016-10-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously treated patients with non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pathologically confirmed non-small-cell lung cancer 2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with peripheral blood and/or pleural effusion that can be taken 3)Have measurable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria. 4)Twenty or more years old at the time of informed consent 5)Eastern Cooperative Oncology Group Performance Status (ECOG PS)0-2 6)Have adequate organ function within 14 days before entry 7)Estimate life expectancy of at least 12 weeks 8)Have signed an informed consent document

Exclusion criteria

Exclusion criteria: 1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray 2)Clinically significant drug allergy 3)Presence of other active malignancy 4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage 5)Positive serum HBs antigen 6)With severe infection, cardiac diseases, diabetes, hypertension, other severe complication 7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks. 8)Pregnancy or lactating patients

Design outcomes

Primary

Measure	Time frame
Immune-profiling of fresh peripheral blood and/or pleural effusion at three time points: pretreatment, post 1st dose, post 2nd dose	—

Secondary

Measure	Time frame
Continue to collect blood and/or pleural effusion monthly for analyzing immune profile after discontinuation of anti PD-1 antibody treatment.	—

Countries

Japan

Contacts

Public ContactShohei Koyama

Osaka University Graduate School of Medicine Department of Respiratory Medicine, Allergy and Rheumatic Diseases

koyama@imed3.med.osaka-u.ac.jp06-6879-3833

Outcome results